Wound healing electrode set

ABSTRACT

The set for the electrical stimulation of a patient, comprises a backing, at least one electrically active zone and a wire connected to said electrically active zone for connection to a stimulator. Said backing has the shape of a bandage or of a plaster.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57.

TECHNICAL FIELD

The present invention concerns a wound healing electrode set and adevice using such an electrode set.

The present invention also concerns an electrode set for an electricallyinduced wound healing that can be adjusted to the wound size.

BACKGROUND ART

Devices using electrical stimulation for wound healing and alsostimulate bone growth are known in the art. For example, the followingdocuments all relate to this field: WO 84/01298, EP 0 367 320, U.S. Pat.No. 4,846,181, U.S. Pat. No. 4,919,138, U.S. Pat. No. 4,982,742, U.S.Pat. No. 5,158,081, U.S. Pat. No. 5,218,973, U.S. Pat. No. 5,395,398,U.S. Pat. No. 5,433,735, U.S. Pat. No. 5,814,094, U.S. Pat. No.5,861,016, DE 198 09 218, WO 02/068045, U.S. Pat. No. 6,631,294, WO02/089911, US 2004/0015223, US 2004/0049145, US 2004/0147977, WO2004/080534, US 2005/0119715, U.S. Pat. No. 6,907,294, WO 2005/096979,US 2005/0244484, US 2006/0173523 and US 2006/0189912.

For example, EP 0 367 320 discloses a system for the treatment of woundsby means of electric stimulation with an electric wound compress, areturn electrode, an electric generator and cables for forming electricconnections between the elements.

In U.S. Pat. No. 4,846,181, a wound healing device is disclosed using awound electrode placed preferably at the wound, a dispersive electrodepositioned at a distance from the wound and a stimulation unit.

In U.S. Pat. No. 5,218,973, a signal generator provides an electricaloutput signal and this signal is coupled through a cable, a connectorand an active electrode to a soft tissue wound site of a patient. Areturn electrode engages a separate area of the patient spaced from thewound site and a return path to the generator is provided throughanother cable.

U.S. Pat. No. 5,861,016 discloses a method for healing a wound of apatient using an electrical stimulator and acupuncture needles. Themethod involves the step of positioning a plurality of acupunctureneedles coupled to the electrical stimulator substantially around thewound. The next step include applying a current to said acupunctureneedles.

In U.S. Pat. No. 6,631,294, an electrode system is provided thatgenerates a current flow that envelops and permeates an entire woundsite. The electrode system includes two electrodes that are shaped andoriented to cause the current to flow form one electrode through thewound to the other electrode. A first electrode is applied to the woundsite and a second electrode encircles the first electrode and is appliedto the skin surrounding the wound site.

In WO 2005/096979, the apparatus comprises an array of needles thatpenetrates the skin and serve as electrodes to deliver radio frequencycurrent or other electrical or optical energy into the tissue beingtreated, causing thermal damage in controlled patterns.

SUMMARY OF THE INVENTION

It is an aim to improve the known devices for stimulation and treatmentof the body of the user, for example the treatment of wounds.

More specifically, it is an aim of the present invention to provide asystem and electrodes or electrically active zones that are easy to use.

To this effect, the present invention comprises an electrode set thatcan be applied to a region of the body of the user, for example awounded region.

In the present description, the notion of “electrode” should beunderstood as “electrically active zone” and both notions will be usedindifferently in the present application.

Another idea of the present invention is to combine a bandage, such as aspunlace backing, or a plaster (for example a sticking plaster) with atleast two electrically active zones that is applicable to the body of auser.

According to the invention, the bandage or plaster can be easily applieddirectly onto a painful area (for example the ankle, knee or elbow, orany other part of the body) or a wound to be healed. The use of abandage made of a spunlace backing or a plaster brings a mechanicalsupport to the system and also allows a better application of the activezones against the body of the user.

Of course, the present invention is not limited to a spunlace backing(only given by way of example): any textile that can be used as abandage can be combined with the electrically active zones according tothe teaching of the present invention. For example, bandages can be madefrom generic cloth strips, to specialized shaped bandages designed for aspecific limb or part of the body, i.e. knitted, woven and non-wovenmaterial.

Preferably, the bandage used, or at least a part of it, is elasticallydeformable. Of course, non-elastic bandages might also be used or acombination of both.

In the case of a sticking plaster, any suitable material may be used:woven fabric, plastic, or latex rubber.

The active zones may be electrodes of the “EASY” type, i.e. one supportlayer with two active zones, but one may also envisage two separatesingle active zones attached to the backing. An example of an electrodeof the “EASY” type mentioned above is disclosed in US application2006/0116565 in the name of Axelgaard.

The active zones may be attached in many ways to the backing (bandage orplaster): for example by using a Velcro™ system placed on the inner sideof the bandage/plaster. One may also directly use the backing fabricpresent with electrodes and extend said backing to form the bandage. Inanother variant, the electrically active zones can be glued to or sewnon the backing. Preferably however, the active zones are detachable fromthe backing to allow a reuse of the elements of the system.

In another embodiment, the electrode set according to the presentinvention comprises a single patch or plaster with active zones. Saidpatch can be adjustable to the size of a wound when used on such woundor to the user.

In this case, the patch size can be adapted in one direction or in twodirections to the size of the wound or of the user.

Preferably, to this effect, the patch comprises a one-time stretchablematerial placed between the electrically active zones to allow the sizeadaptation.

An advantage of the patch according to the present invention is that itcan be easily adapted to various wound and/or user sizes.

The advantages of the present invention are numerous. For example, itmay be applied directly onto a wound or painful area, allowing a directelectrical treatment (for example transcutaneous electrical nervestimulation (TENS) or any other as desired). Also, the use of a bandageor a plaster brings mechanical support to the treated body part of theuser.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be better understood by the description ofseveral embodiments and of the drawings in which

FIG. 1 illustrates a first embodiment of the set according to theinvention;

FIG. 2 illustrates a variant of the embodiment of FIG. 1;

FIGS. 3-5 illustrate a second embodiment and variants therefrom inperspective;

FIGS. 6-7 illustrate a third embodiment in top view and bottom view,respectively and

FIG. 8 illustrates a fourth embodiment in bottom view.

DETAILED DESCRIPTION

A first embodiment is illustrated in perspective in FIGS. 1 and 2. Inthis embodiment, the set comprises a backing material 1, for examplehaving the shape of a bandage or plaster, said backing having a zone 2with attachment means, for example a zone comprising Velcro™ orequivalent means. In addition, the set comprises an attachableelectrical element 3 which comprises electrically active zones 4, 4′,4″, 4′″ (for example four as illustrated but this number may be variedif necessary). All said electrically active zones 4-4′″ are connected toa wire 5, 5′, 5″, 5′″ for connection to a stimulation device.

The electrical element 3 comprises a zone 6 which corresponds to zone 2of the backing for attachment of the element 3 to the backing 2, forexample as is done with Velcro™. The backing can be used as a bandageand once the electrically active zones are applied to the desired bodypart of a user, the device can be attached to said part as a bandage,thus maintaining the active zones against the user.

In the variant of FIG. 2 where similar parts are referenced as in FIG.1, the backing 1′ for example has the shape and size of a belt andcomprises two additional zones 7, T with attachment means, for examplesuch as Velcro™ for attachment of the backing 1′ as a belt. Of course,other equivalent means may be used for attaching the two ends of thebacking 1′, instead of zones 7, T with Velcro™.

A second embodiment is described with reference to FIGS. 3 to 5. In thisvariant, the backing material 20 in the shape of a bandage carries twoseparate electrodes 21, 22, each connected to a connection wire 23, 24.As in the first embodiment, the backing can be made of a spunlacebacking, a bandage or any other equivalent material.

FIG. 4 illustrates a top perspective view of the set of FIG. 3 and thesame elements are referenced with the same numbers. In addition, in thisfigure, one has represented in more detail connectors 25, 26 that are atthe end of wires 23, 24 for connection to a stimulation device (notshown).

In the variant of FIG. 5, the wires 23, 24 pass through the backingmaterial 20.

In embodiment illustrated in FIGS. 6 and 7, the backing 30 comprises twolateral zones 31, 32 carrying the electrically active zones 33, 34 and adeformable central zone 35 allowing to adapt the plaster size to thearea to be treated, shown also in the detail of FIG. 7.

The deformable zone 35 can be an elastically deformable zone or a“one-time unfold” (i.e. plastically deformable) zone which remains in anunfolded configuration once applied. The elastic zone 35 can be madedirectly in the backing, for example by cutting said zone intonet-shaped zones which can be deformed laterally. This zone 35 can alsobe made of a specific material with a dedicated shape or by otherequivalent means.

Preferably, this embodiment includes at least one lateral flap 36 or 37which allow a user to pull said flap apart 36 or 37 and thus adapt thesize of the plaster to the area on which it is being applied bydeformation of the elastic zone. Preferably, it comprises two flaps 36,37, one on each side of said lateral zones to carry out this “pullingapart” operation. Also, this embodiment includes wires 38, 39 forconnection to a device, for example a stimulator. Of course, these wiresmay comprise connectors for allowing a detachable connection to saiddevice as illustrated in other embodiments of the invention.

A further embodiment of the patch according to the present invention isillustrated in FIG. 8. In this embodiment, the patch comprises a layerof material 40, for example a backing material that is non-conductive.

On this backing, one has placed four electrically active zones 41-44which form electrodes applied to the user of the patch. As illustratedin FIG. 8, the patch comprises four electrically active zones. Ofcourse, it is possible to use less (for example two) such zones, or morethan four zones.

In the centre zone, there is situated an opening 45 for avoiding a woundto be covered by the patch.

Preferably, this backing 40 comprises several parts that are folded 46to 49 (for example folded zones) and that allow the patch size to beadapted to the wound or to the body of the wearer. Typically, to formthese folds 46-49, backing material is made of a one-time stretchmaterial allowing the user to stretch the patch to the proper size andthen place said patch without worrying that it will come back to itsoriginal size and shape.

In the representation of the FIG. 8, one has illustrated fourelectrically active zones 41-44 with four folded zones 46-49, but it isalso possible with such four electrically active zones to use less thanfour folded zones, for example only two, preferably zones 46 and 48 or47 and 49 for symmetry. Of course this is only an example and otherconfigurations are possible.

Also, if less (or more) than four electrically active zones are used,the number of folded zones can be decreased (or increased) accordingly.

On the right side, one has also represented the contacting wires 50allowing a contact to a stimulator (not shown in this figure), saidwires being connected at their other end to the electrically activezones 41 to 44. Of course, in a variant, it is possible to use a singleconnector in which all the wires are integrated instead of individualwires each with one single connector each.

In the present invention, the electrically active zones may be standardsticky hydrogel electrodes or made of non-sticky material if the set isused with a garment of a bandage allowing the maintain a tight contactbetween the active zones and the skin.

Various shapes, for the backing, bandage or plaster and also theelectrically active zones and the fold zones, may be envisaged and theillustrative example given should not be construed as limiting. Forexample the shapes could be adapted to the body area on which it will beused.

For the folded zones, instead of one-time stretchable material, one mayuse a very elastic textile material (for example a spunlace backing withhigh elasticity).

Preferably, the backing is slightly larger than the electrically activezones to allow a user to hold the set appropriately and stretch it tothe right (or desired) size.

When set comprises an opening (such as an opening 45), this allows awound care even when the set is applied to a patient and without removalof the set.

In a variant, it is possible to use an elastic gauze for protection ofthe wound for example over or in the opening 45.

In a further variant, it is possible to add an active agent on at leastone of the electrically active zones of the embodiments described aboveto allow the application of medication via iontophoresis.

In another variant, it is possible to add in the opening an elasticelectrically conductive gauze. Such a gauze would allow, for example toapply an electric treatment directly into the wound.

Regarding the electrical stimulation, any stimulation may be envisaged.For example, during wound care but not only at this moment, it ispossible to apply a TENS waveform to reduce pain. Other signals may beused, for example signals that improve the healing of a wound.

As one will readily understand from the above description, manystimulation signals and method may be carried out with the present set.For example one may apply a TENS stimulation for pain relief. In avariant, one may apply a stimulation that has a wound healing effect. Inanother variant, one may use the set to carry out a iontophoretictreatment (with the addition of a suitable active agent one at least oneelectrically active zone).

As one will understand, the active zones of the above describedembodiments preferably include each a gel pad for contact with the skinof the user.

The connection wires can pass through the backing/plaster or not. Theycan be free as represented in the figures or joined in a connector tofacilitate the connection and avoid loose single wire. If the connectoris asymmetrical, this can ensure that a wrong connection is carried out.Also, to this effect the connector may comprise specific means to ensurea proper and easy connection.

Of course, the embodiments described above are non-limiting illustrativeexamples and variations with equivalent means are possible. For example,it is possible to use more than two active zones.

The type of active zones used may vary. They can be of the “EASY” typementioned above, or of another type: for example pads with electricallyconductive zones as known in the art.

In addition, other equivalent means than Velcro™ may be used to attachthe electrode(s) or pads forming the active zones to the bandage. Theycan be glued or attached to the bandage by any other equivalent means.

As will be readily understood, the set of the present invention can beused in combination with a electrical stimulator for applying differentstimulation to the wearer. Such stimulations can be a TENS stimulation,or an EMS stimulation or any other suitable stimulation applicable withsuch devices. Typical methods carried out by the present invention canbe a healing method using an electrical stimulation. The deviceaccording to the invention may also be used for a wound healing methodusing electrical stimulation or other treatment methods, such a choicebeing linked to the signal applied to the patient and also to the numberand positioning of the electrically active zones. As a skilled workerwill understand, many methods are possible.

What is claimed is:
 1. An electrostimulation device, comprising: abacking having an outside perimeter edge surrounding the backing, thebacking comprising a first non-conductive deformable zone of the backinghaving a first edge and a second edge wherein the first non-conductivedeformable zone comprises several parts of a material of the backingthat are folded between the first and second edges; a first lateral zonehaving an outside edge coextensive with a portion of the outsideperimeter edge of the backing and an inside edge coextensive with thefirst edge of the first non-conductive deformable zone, a second lateralzone having an outside edge coextensive with another portion of theoutside perimeter edge of the backing and an inside edge coextensivewith the second edge of the first non-conductive deformable zone, andwherein the first non-conductive deformable zone is located between thefirst lateral zone and the second lateral zone, the first non-conductivedeformable zone being expandable so as to increase a distance betweenthe first lateral zone and the second lateral zone in a first direction;and a plurality of electrically active zones located on the backing suchthat the backing covers one side of each of the plurality ofelectrically active zones, the plurality of electrically active zonesincluding a first electrically active zone located on the first lateralzone, and a second electrically active zone located on the secondlateral zone.
 2. The device of claim 1, wherein the backing furthercomprises an opening extending through the backing, an edge of the firstnon-conductive deformable zone and an edge of the first lateral zoneeach forming a portion of an edge of the opening.
 3. The device of claim2, wherein the first deformable zone is extendable in the firstdirection, and wherein the backing comprises a second non-conductivedeformable zone that is extendable in a second direction, the seconddirection being different from the first direction, wherein the secondnon-conductive deformable zone comprises several parts of a material ofthe backing that are folded.
 4. The device of claim 3, wherein thebacking further comprises a third non-conductive deformable zoneextendible in the first direction and a fourth non-conductive deformablezone extendible in the second direction, the opening separating thefirst non-conductive deformable zone from the third non-conductivedeformable zone, and the opening further separating the secondnon-conductive deformable zone from the fourth non-conductive deformablezone.
 5. The device of claim 4, wherein the first electrically activezone is positioned adjacent to the first non-conductive deformable zoneand the second non-conductive deformable zone; the second electricallyactive zone is positioned adjacent to the first non-conductivedeformable zone and the fourth non-conductive deformable zone; andwherein the plurality of electrically active zones further comprise athird electrically active zone located on the backing adjacent to thethird non-conductive deformable zone and the fourth non-conductivedeformable zone, and a fourth electrically active zone located on thebacking adjacent to the second non-conductive deformable zone and thethird non-conductive deformable zone.
 6. The device of claim 4, whereinthe first deformable zone and the second deformable zone comprise aone-time stretchable material.
 7. The device of claim 6, wherein theone-time stretchable material is plastically deformable.
 8. The deviceof claim 3, wherein the first direction and second direction aresubstantially perpendicular.
 9. The device of claim 2, furthercomprising a gauze positioned over the opening.
 10. The device of claim9, wherein the gauze is conductive.
 11. The device of claim 1, whereinthe first deformable zone comprises an elastic material.
 12. The deviceof claim 1, wherein the backing is non-conductive.
 13. The device ofclaim 1, wherein the backing comprises plaster.
 14. The device of claim1, wherein at least one of the plurality of electrically active zones isdetachable from the backing.
 15. The device of claim 1, wherein at leastone of the plurality of electrically active zones comprises an activeagent for iontophoretic delivery.
 16. The device of claim 1, furthercomprising a connector for connecting to the plurality of electricallyactive zones.
 17. The device of claim 1, wherein the device is atranscutaneous electrical nerve stimulation (TENS) unit.